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Uro-Kit® Reusable Latex Leg Bag System 9 oz.

FDA UDI

Class II (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Uro-Kit® Reusable Latex Leg Bag System 9 oz. FDA UDI
Generic Name
Open-ended wearable urine collection bag, non-sterile FDA UDI
Device Name
BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SMALL, 9 FL. OZ. (270 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #8509, 1 Upper Fabric Leg Strap #6344, 1 Bottle of Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adapter with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions. FDA UDI
Model / Reference
98509 FDA UDI
Description
BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SMALL, 9 FL. OZ. (270 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #8509, 1 Upper Fabric Leg Strap #6344, 1 Bottle of Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adapter with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions. FDA UDI

Identifiers

Catalog Number
98509 FDA UDI
Primary DI / UDI-DI
00792293985095 FDA UDI
FDA Product Code
MDZ FDA UDI
FFA FDA UDI
EXJ FDA UDI
NNW FDA UDI
KNX FDA UDI
GMDN Term
Open-ended wearable urine collection bag, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6992 FDA UDI
876.5090 FDA UDI
876.5250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 9 Fluid Ounce FDA UDI
Total Volume — 270 Milliliter FDA UDI
Height — 6.75 Inch FDA UDI
Weight — 1.70 Pound FDA UDI
Width — 6.0 Inch FDA UDI
Depth — 10.0 Inch FDA UDI

Category: Open-ended wearable urine collection bag, non-sterile

Uro-Kit® Reusable Latex Leg Bag System 9 oz. by Urocare Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-ended wearable urine collection bag, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Urocare Products, Inc.

Sources (1)

  • FDA UDI 09b624b4-e93c-4412-b020-7d35c806299e 36 fields · synced May 31, 2026